Superior Hypogastric Plexus Block Versus Pulsed Radiofrequency for Chronic Pelvic Cancer Pain

Superior Hypogastric Plexus Block and Pulsed Radiofrequency on Dorsal Root Ganglia of Sacral Nerves for Chronic Pelvic Cancer Pain

Cancer-related pain represents a major challenge for both clinicians and patients. This pain can be associated directly with the cancer or with certain treatments administered to the patient. 52.1% of cancer patients suffer from pain and that 62.6% are not satisfied with the current pain treatment. Pain prevalence is high in developing countries due to late diagnosis and major impediments to opioid access

Study Overview

• Status: Unknown
• Conditions: Chronic Pelvic Cancer Pain
• Intervention / Treatment: Procedure: superior hypogastric plexus block; Radiation: pulsed radiofrequency

Detailed Description

pelvic cancer is a broad term encompassing malignant tumors of the bladder, prostate, cervix, endometrium, ovaries, and uterus, among others. Pain associated with pelvic cancer is one of the most debilitating symptoms experienced by affected patients. Multiple studies demonstrate that the prevalence of pain in patients with pelvic cancer is >50%, and can be upwards of 60% to 70% in patients with advanced or metastatic disease . Cancer patients with extension of tumor into the pelvis may experience severe pain. Oral or parenteral opioids may not only fail to provide relief, but may cause excessive sedation and other side effects. More invasive approaches may thus be needed to control pain and improve the quality of life. Since pelvic cancer pain is visceral in most cases, this could be achieved with percutaneous chemical neurolytic block of the superior hypogastric plexus . The superior hypogastric plexus is located at the anterior aspect of the L5 and S1 vertebrae, and traverses the disk between these levels. It is an extension of the aortic plexus below the aortic bifurcation, and contains almost exclusively sympathetic fibers and visceral afferents . Afferent pain fibers innervating pelvic organs travel with sympathetic nerves, trunks, ganglia, and rami; thus, interrupting the sympathetic chain at this level can be used to treat pelvic cancer pain. Several studies examined the use of superior hypogastric plexus block in the treatment of pelvic cancer pain. Although the authors reported a mean reduction in pain of 70%, neither the follow-up period nor the proportion with a successful prognostic block were noted. Radiofrequency utilizes a high-frequency alternating current that is passed from the needle electrode into the surrounding tissue, resulting in frictional heating and necrosis. Due to the accuracy of lesions produced by radiofrequency ablation, there has been growing interest in the use of this technique for neurolysis of nerves as it offers the potential of accurate nerve destruction ablation, with a predictable and controlled ablative lesion. Another advantage of radiofrequency ablation is that it has an immediate effect unlike alcohol and phenol, which may take up to 1 week or 10 days to achieve neurolysis .

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatma Ahmed Abdel Aal, professor; Phone Number: 002 01113221317; Email: Fatmaabdelal23@yahoo.com
• Study Contact Backup: Name: Ashraf Amin, professor; Phone Number: 002 01153131503; Email: ashrafkena@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• sympathetically maintained pelvic, perineal pain
• pain is no longer controlled with oral morphine sustained release tablets 30 mg
• excessive sedation or other side effects from oral morphine sustained release tablets 30 mg or amitryptyline tablets 25 mg
• age between 18-70 years

Exclusion Criteria:

• patient refusal
• patients with coagulopathies
• allergy to constant dyes or phenol
• patients receiving radiation or chemotherapy within 4 weeks of neurolytic block
• patients with major or moderate cardiac/respiratory incapacitating diseases
• liver and renal failure
• patients younger than 18 years and older than 70 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the study group one; 20 patients with superior hypogastric plexus block	Procedure: superior hypogastric plexus block; nerve plexus block
Experimental: the study group two; 20 patients with superior hypogastric plexus block combined to pulsed radiofrequency on sacral nerve roots 2,3 and 4	Procedure: superior hypogastric plexus block; nerve plexus block; Radiation: pulsed radiofrequency; pulsed radiofrequency on sacral nerve roots 2,3 and 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue score for pain	Points on a scale	2 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004.
• Hetta DF, Mohamed AA, Abdel Eman RM, Abd El Aal FA, Helal ME. Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain. Pain Physician. 2020 Mar;23(2):149-157.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2019
• Primary Completion (Anticipated): June 20, 2020
• Study Completion (Anticipated): December 20, 2020

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Pelvic Neoplasms; Cancer Pain
• Other Study ID Numbers: MEHG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Clinical Study Report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No